ctDNA in Cutaneous Squamous Cell Carcinoma
Part of paid clinical trials in Boston, Massachusetts.
- Sponsor
- Massachusetts Eye and Ear Infirmary
- Study ID
- NCT06875609
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Blood and Tissue Collection — DIAGNOSTIC_TESTBlood samples, and tissue samples will be collected from the participants, and used to determine whether circulating tumor DNA (ctDNA) testing can help monitor treatment in patients with CSCC, and to determine how ctDNA levels change in patients.
Study Details
The purpose of this study is to test the potential for a liquid biopsy assay to detect residual disease after surgery in patients with cutaneous squamous cell carcinoma as well as the potential for this assay to monitor response to immunotherapy treatment.
Key Dates
- Start date
- Mar 24, 2025
- Status verified
- Mar 2026
- Primary completion
- Apr 30, 2028
- Completion
- Apr 30, 2029
Study Design
- Enrollment
- 60 participants (estimated)
Arms
- Arm: Post-Operative CohortCutaneous Squamous Cell Carcinoma cancer patients treated with surgery.
- Arm: Neoadjuvant CohortCutaneous Squamous Cell Carcinoma patients treated with Neoadjuvant immunotherapy.
- Arm: Definitive Immunotherapy CohortCutaneous Squamous Cell Carcinoma patients treated with definitive immunotherapy.
Primary Outcome Measure
2-year recurrence-free survival (RFS) in patients with detectable vs no detectable ctDNA after surgery [ Time Frame: 24 Months ]
Central Contacts
- Michael Cheung, MSc, CCRP6175736060
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Massachusetts Eye and Ear | Boston | Massachusetts | 02114 | Sophia Shalhout, PhD (PRINCIPAL_INVESTIGATOR) |
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